The Quality Project Associating services entails focussing on quality oversight and project support and has following responsibilities:
* Investigate and document Quality Assurance related deviations and escalate issues or prepare recommendations as appropriate to the Team Leader in a timely manner
* Coordinate cross functional investigations in case of complex root causes and work closely with manufacturing, packaging and lab operations, supporting departments and/or third parties
* Perform and/or evaluate investigations, root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations
* Report significant quality issues to regulatory agencies, according to local legislation (e.g. FAR and BPDR for US marketed products and other BOHs as applicable)
* Participation in operations, product and process teams and Daily Operations Review meetings
* Perform trending analyses, define and/or evaluate necessary actions and verify effectiveness of these actions via trend reports
* This position can be requested to participate in assignments defined by the Team Leader, Lead or Sr. Manager
* The Quality Specialist Operations will respect the PGS vision, mission, values and behaviors in order to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time and cost
* Support continuous improvement initiatives in the department to improve processes and act on key KPI’s
Qualifications:
* Master's degree in a relevant scientific or engineering discipline, such as Industrial Engineering, Civil Engineering, Bio-engineering, or (Industrial) Pharmacy, or equivalent experience in fields like Biochemistry or Biotechnology
* Know-how of project management within the pharmaceutical or related industries, with a strong focus on GMP-regulated and aseptic environments
* Strong analytical and problem-solving abilities, excellent organizational skills, and a meticulous, accurate, and quality-conscious work approach
* Strong communication, interpersonal, and technical writing skills to effectively collaborate with cross-functional teams and external stakeholders
* A perfect command of Dutch and good knowledge of English (written and oral) are required